Summary
This course agenda aligns with the thematic processes defined in IEC 62366 and HE75, covering all stages and incorporating preparation of summary documentation, integration into risk management and design control processes, and regulatory evaluations. Practical examples include an autoinjector for a rare muscular disorder, a transdermal patch for a common disorder, and a metered dose inhaler for a new respiratory illness.
Learning Objectives
- Understand the definitions and key concepts of human factors and combination products.
- Recognize the regulatory and standards landscape for combination products.
- Conduct comprehensive risk assessments to identify potential hazards.
- Integrate risk management processes using the ISO14971 framework.
- Perform formative assessments to evaluate early design concepts.
- Develop and implement study designs for human factors evaluation.
- Integrate ergonomics into the design of combination products.
- Conduct summative assessments and interpret results to enhance product safety and usability.
- Prepare summary documentation for regulatory submissions.
- Understand how regulatory agencies evaluate human factors and ergonomics requirements.
Key Topics
- Regulatory and Standards Overview
- EMA & FDA
- IEC62366
- HE75
- ISO14971
- ISO13485
- Key guidance documents including the FDA human factors Guidance
- User-Centered Design Process
- Study Design for Human Factors
- Summative Assessment
- Regulatory Evaluation (Regulators and Notified Bodies)
Who should attend?
This course is suitable for all those involved in:
- Engineering & Device Development
- Product development
- Usability and human factors engineering
- Packaging
- Quality
- Regulatory Affairs
- Risk
- Marketing
Past participants
- Global Head External Quality, Biogen
- QA Manager, F. Hoffmann-La Roche
- Senior Manager GLP/GMP, Merz Pharmaceuticals
- Senior Technical Regulatory Affairs Manager, Idorsia Pharmaceuticals
- Senior Technical Steward Devices, Novartis
- Manager, External Manufacturing Management, Ferring
- R&D Engineer, Cook Medical
- Principle Scientist Lead Combination Products, Lonza
- Process Engineer, Novo Nordisk
- Quality Manager, Boston Scientific
- Global DRA Project Leader, Idorsia Pharmaceuticals
- Design Team Manager, Owen Mumford
- Development Engineer, Leo Pharma
- Regulatory Affairs Manager, Novavax
- Head of Regulatory Affairs, Vectura
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 7 days
- Training in digital format
- Digital and LinkedIn certificates
Trainers
Human Factors for Combination Products
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